Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:13 - 18
Updated:8/31/2018
Start Date:December 2012
End Date:May 2019

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The goal of this study is to characterize the function and efficacy of the bioactive
nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The
three specific aims of this study are 1) To address the impact of maternal vitamin D status
on inflammation and infections across pregnancy using retrospective data, 2) To address the
impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections
across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D
status during pregnancy on inflammatory mediators at the level of the placenta.

Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and
delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory
markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol
and parathyroid hormone) and infections and inflammatory complications abstracted from
medical charts. Placental samples were collected from a subset (n=132) of these pregnant
teens and these tissues will be analyzed using genome wide microarray of messenger
ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate
group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a
vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements
(200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic
hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation
(23-28 weeks) and at delivery. Inflammatory processes and infections reported across
pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.

Inclusion Criteria:

- Female adolescents between 13 and 18 years of age

- Between 12 and < 30 weeks pregnant

Exclusion Criteria:

- HIV-infection

- Eating disorders

- Malabsorption diseases

- Diabetes mellitus

- Gestational diabetes

- Pregnancy induced hypertension or elevated diastolic blood pressure (>110)

- Steroid use

- Substance abuse history

- Taking medications known to influence Ca or vitamin D status

- Diagnosis of elevated blood lead concentrations during childhood

- Smokes tobacco
We found this trial at
1
site
Rochester, New York 14620
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Rochester, NY
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